Robert J. Boumis  |  March 5, 2015

Category: Legal News

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Midwife checks newborn babyZofran is an anti-nausea drug, but it is not approved for use in pregnant women. Despite this,  Zofran is frequently prescribed to treat morning sickness and may be the cause of many birth defects.

Under federal law, drug makers must seek approval before they sell a drug to the public. The approval process involves strict protocols to ensure safety and efficacy.

In the United States, the Food and Drug Administration (FDA) designs the protocols for this testing. Approval for a drug is very specific, drug makers can only market drugs for FDA-approved purposes. If it’s later found that a drug can treat more than one condition, drug makers must seek approval for each separate use of the drug.

However, doctors are allowed to prescribe drugs beyond their FDA-approved uses, but this “off-label” usage cannot be advertised by the drug maker until they get FDA approval for the new use.

In 2012, GSK settled a federal, civil false claim lawsuit alleging GSK had promoted Zofran for the treatment of morning sickness in pregnant women despite being approved only for post-operative nausea, and that GSK had paid doctors kickbacks for prescribing Zofran. In 2012, GSK settled that lawsuit along with three similar lawsuits regarding other GSK products for $1.043 billion.

Zofran has been approved to treat the extreme nausea that goes hand-in-hand with surgical anesthesia, chemotherapy, and radiation therapy. However, it is not approved to treat morning sickness, since Zofran’s makers have not tested its safety on pregnant women.

Additionally, a variety of studies have suggested that Zofran may be pose dangers to a baby while in utero.

A 2011 study funded by the Centers for Disease Control and Prevention found that taking Zofran while pregnant doubled the risk of a variety of birth defects. A study published in Denmark drawing data from the medical records of 900,000 who took Zofran found similar results to the CDC study.

Curiously, another Danish study with a slightly smaller sample population of 600,000 women did not find the same risk of Zofran birth defects. Additionally, postmarket surveillance by the FDA has received at least 20 reports of women who had children with birth defects after taking Zofran for morning sickness in 2012.

Despite these findings, the U.S. Food and Drug Administration recently rejected a petition to change Zofran’s drug category, saying in an October 2015 statement that these studies “do not support a determination that there is an increased risk of fetal adverse outcomes.”

A Zofran class action lawsuit investigation has been launched to explore the possibility of Zofran lawsuits against the drug’s makers. Such a Zofran birth defect lawsuit could allege that the makers of Zofran were aware — or reasonably should have been aware — of the serious risks of Zofran birth defects.

These studies are relevant in birth defect lawsuits a as drug companies are legally obligated, not only to test their drugs, but to monitor research journals and postmarket reports for signs that there are unforeseen consequences once their drug is widely used.

Such a Zofran lawsuit could further allege that not only were drug makers aware of the risk of Zofran birth defects, but by aggressively promoting Zofran for off-label purposes, the drug maker increased the risk of Zofran birth defects.

Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The birth defect attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual Zofran lawsuit or Zofran class action lawsuit is best for you. [In general, Zofran lawsuits are filed individually by each plaintiff and are not class actions.] Hurry — statutes of limitations may apply.

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Join a Free Zofran Birth Defects Class Action Lawsuit Investigation

If you or someone you know took Zofran while pregnant and had a baby with a birth defect, you or this person may have a legal claim. See if you qualify by filling out the short form below.

A Zofran birth defect attorney will contact you if you qualify to discuss the details of your potential case at no charge to you.

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